|Position||Manufacturing Science and Technology Engineer||Release Time||2019.10.18|
We are looking for a MSAT engineer to provide process development and engineering support for technology transfers, process validations and GMP manufacturing. Additionally, draft and review protocols, production procedures, and process development reports, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, characterization, and validation to meet regulatory requirements. This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer biological products.
• Lead process-related deviations and provide technical support to manufacturing.
• Investigate, identify root-cause for critical deviations and determine CAPA for manufacturing.
• Write product impact assessments to support deviations.
• Write and review technical documentation (batch records, SOPs, protocols, and reports).
• Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
• Design and execute process validation studies to develop a thorough understanding of operating and performance parameters.
• Perform hands-on activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies.
• Support cross-functional technology transfer teams for cGMP.
• Collaborate with another site or clients to ensure success of scale up/process transfer.
• Execute cell culture or downstream laboratory work while maintaining good laboratory practice.
|Requirements||• Bachelor or advanced degree in Biochemical, Biomedical，Chemical Engineering or a related scientific discipline such as Chemistry or Biology.
• Looking for 5+ years’ relevant experience or Master’s degree with 3+ years’ experience.
• cGMP pharmaceutical MSAT or technical services, technology transfer or process development experience preferred.
• Strong interpersonal and communications skills; written and oral.
• Ability to function in a fast-paced dynamic team environment and balance characterization multiple projects
• Knowledge of cell and gene therapy vector production is desirable.
• Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus.
• Knowledge of data management tools and statistical process controls is preferred.